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International Journal of Bioprinting        Guide about the effects of sterilization on 3D-printed materials for medicine



            Table 9. Mechanical properties of the 3D-printed PA12
             Parameters                                     Mechanical properties
                           Tensile strength (MPa)  Young’s modulus (MPa)  Elongation at yield (%)  Elongation at break (%)
             Control       41.10 ± 2.63        1487 ± 48            1.94 ± 0.23          13.58 ± 5.80
             HPO           37.83 ± 2.57        1170 ± 246           2.24 ± 0.02          16.48 ± 2.19
             AU121         37.67 ± 1.28          990 ± 54           2.11 ± 0.19          16.44 ± 2.96
             AU134         37.10 ± 3.17        1021 ± 65            1.92 ± 0.21          10.80 ± 3.51
            Data are represented as mean ± SD. N = 3 PA12 Control/group; N = 3 PA12 HPO/group; N = 3 PA12 AU121/group; N = 3 PA12 AU134/group.

            all mechanical properties tested, having a mean decrease of   Table 10. Shore hardness of the different elastic materials.
            17.35% in tensile strength.
                                                                Material             Shore hardness A
            3.1.7. PA12                                                   Control     HPO         AU 121
            Figure 9 shows the mechanics of the control sample and
            3D-printed PA12 samples sterilized by HPO, AU121, and         Mean  SD    Mean   SD   Mean   SD
            AU134. The HPO, AU121, and AU134 methods directly   Elastic 50  55.67  1.15  57.00  1.00  57.67  1.15
            influenced the mechanical properties of the material by   Elastic Clear  25.67  0.58  30.33  1.53  27.67  1.53
            decreasing the tensile strength of every sample measured.
            Table 9 shows different mechanical properties of PA12 with   Flexible 80  67.33  2.52  72.67  1.15  72.67  1.53
            different methods. The HPO method resulted in a mean   TPU    63.00  1.73  62.00  2.00  –    –
            decrease of tensile strength by 8.64%, as compared to the   Abbreviation: SD, standard deviation; TPU, thermoplastic polyurethane.
            control group. However, there was no significant difference
            in tensile strength between the samples sterilized by AU121   The obtained results are summarized in Table 11. The
            (9.10%), AU134 (10.78%), and HPO (8.64%) methods; the   results showed that MED610 tensile samples that were
            difference was less than 2% among the three methods.  sterilized by AU134 were the ones that suffered more
            3.2. Shore hardness                                deformation when compared to the control samples. PA12
            Table 10 shows the Shore hardness of the 3D-printed   is the most stable and resistant to deformation among the
            cylindrical elastic samples. In all cases, sterilization   tested materials sterilized by all three methods. In general,
            increased the hardness of materials, although the effect   there were more surface and dimensional differences
            could vary, depending on the material. The Shore   between samples sterilized by AU134 and control samples,
            hardness of Elastic 50 sterilized by HPO or AU121 was   possibly due to the high temperatures and pressures used
            not significantly different when compared to that of the   in this sterilization method, despite the shorter duration of
            control sample, despite the increases of 2.38% and 3.59%   sterilization. When compared to the control samples, the
            for samples sterilized by HPO and AU121. The results also   HPO-sterilized samples showed smaller differences in the
            showed almost similar effect on TPU sample sterilized by   distances.
            HPO, which had an increase of Shore hardness by 1.58%.   Finally, a summary of potential applications for each
            Elastic Clear samples sterilized by HPO and AU121 had   material and AM method is provided as a guide (Table 12).
            a similar increase of Shore hardness by 7.35%. The Shore
            hardness of Flexible 80 appeared to be the most affected,   4. Discussion
            evidenced by an increase of 15.36% and 7.23% in samples   4.1. Materials and sterilization processes
            sterilized by HPO and AU121, respectively.
                                                               4.1.1. Thermoplastic materials
            3.3. 3D printing accuracy                          According to the experiment results, it can be concluded
            The result of the comparison of the meshes (between the   that hard thermoplastic materials such as PLA, ABS, TPU,
            3D-printed samples with and without sterilization) is   or thermoplastic elastomer (TPE) should be sterilized using
            represented by a color map and a histogram showing the   non–heat-based sterilization methods such as HPO. Other
            distance differences in millimeters in all axes between the   studies reached the same conclusion, finding deformation
            points of each surface mesh (see Figure 11). The mean with   when autoclave or dry heat processes were used [27,37,38] . For
            a confidence interval of 95% and standard deviation of all   example, in our results, PLA showed similar tensile strength
            distances was computed. The rest of the images can be seen   and elongation at break in samples sterilized by HPO and
            in Supplementary File (Figures S2–S35).            control samples. Therefore, the use of HPO sterilization is


            Volume 9 Issue 5 (2023)                        156                         https://doi.org/10.18063/ijb.756
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